Table 3 Demographic information of datasets T1.1-T1.4, and the merged dataset.
T1.2. - DirectNet - CGM in Young Children | T1.3. - DirectNet - Metabolic Control | T1.4. - RT-CGM | Merged Dataset | ||||
|---|---|---|---|---|---|---|---|
All | Used Data | All | Used | All | Used Data | Used | |
Participants | T1D | T1D | T1D | T1D | T1D | T1D | T1D, At-risk/pre-diabetes or T2D |
n | 146 | 30 | 71 | 19 | 451 | 33 | 247 |
Age - Mean (SD) | 7.2 ± 1.8 | 6.9 ± 2 | 12.9 ± 5.6 | 13.3 ± 6.4 | 25 ± 15.8 | 21.2 ± 11.8 | 39.6 ± 21.6 |
BMI - Mean (SD) | 17.4 ± 2.2 | 17.3 ± 1.9 | 18.4 ± 3.5 | 18.3 ± 3.4 | 23.5 ± 4.4 | 23.1 ± 4.7 | 26 ± 6.4 |
Gender | |||||||
Female | 79 (54.1%) | 17 (56.7%) | 25 (35.2%) | 8 (42.1%) | 248 (55%) | 21 (63.6%) | 150 (60.7%) |
Male | 67 (45.9%) | 13 (43.3%) | 46 (64.8%) | 11 (57.9%) | 203 (45%) | 12 (36.4%) | 97 (39.3%) |
Race/Ethnicity | |||||||
Non-Hispanic White | 112 (76.7%) | 23 (76.6%) | 63 (88.7%) | 19 (100%) | 417 (92.6%) | 30 (90.9%) | 135 (54.7%) |
Hispanic or Latino | 14 (9.6%) | 2 (6.6%) | 3 (4.2%) | 0 | 15 (3.3%) | 1 (3.0%) | 102 (41.3%) |
Black/African American | 6 (4.1%) | 1 (3.3%) | 1 (1.4%) | 0 | 7 (1.6%) | 1 (3.0%) | 4 (1.6%) |
Asian | 4 (2.7%) | 1 (3.3%) | 0 | 0 | 2 (0.4%) | 0 | 1 (0.4%) |
Other/ Unknown/More than one race | 10 (6.8%) | 3 (10%) | 4 (5.6%) | 0 | 10 (2.2%) | 1 (3.0%) | 5 (2%) |
Laboratory HbA1c | |||||||
HbA1c < 5.7% | 0 | 0 | 0 | 0 | 6 (1.3%)** | 0 | 40 (16.2%) |
5.7%≤ HbA1c ≤ 6.4% | 0 | 0 | 1 (1.4%) | 0 | 47 (10.5%) | 5 (15.2%) | 47 (19%) |
HbA1c > 6.4% | 146 (100%) | 30 (100%) | 69 (98.6%)* | 19 (100%) | 396 (88.2%) | 28 (84.8%) | 160 (64.8%) |
Arm/Group | |||||||
Control | 72 (49.3%) | 6 (20%) | 50 (70.4%) | 0 | 219 (48.6%) | 0 | NA |
Active | 74 (50.7%) | 24 (80%) | 21 (29.6%) | 19 (100%) | 232 (51.4%) | 33 (100%) | NA |
Data Segments | |||||||
CGM Length | Phase 1: 26 weeks Phase 2: 26 weeks | 2 segments > 45 days | up to 2 years | ∽9 months of consecutive data | Phase 1: 26 weeks Phase 2: 26 weeks | 3 segments > 45 days | 2 segments > 45 days |
HbA1c | NA | t1 (equal to t2), and t3 | NA | t1, t2, tP3 | NA | t1, t2, t3 | t1 (equal to t2), and t3 |
NCT | NCT00760526 | NCT00891995 | NCT00406133 | - | |||
